Temena

Basic Information

• Brand Name: Temena
• Primary DI: 03700339710683
• Version / Model: 09120-18
• Catalog Number: 09120-18
• Company Name: Temena GmbH
• Labeler DUNS: 329515725
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-28
• Public Version: 3
• Public Version Date: 2019-07-22
• Public Version Status: Update
• Public Device Record Key: 561e53f3-2d3e-4cda-8d13-6c32d2b1bfd4

Device Description

Kit for peripheral nerve blocks

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAZ	Anesthesia Conduction Kit	Anesthesiology	868.5140	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46383	Peripheral anaesthesia catheter set, non-medicated	A collection of devices intended for the continuous-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block. It includes an anaesthesia needle and an anaesthesia catheter usually with additional devices utilized for the procedure (e.g., connectors, catheter holder). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	03700339700684	GS1	Box	10	In Commercial Distribution
Primary	03700339710683	GS1

Device Sizes

Type	Value	Unit	Text
Needle Gauge	18	Gauge
Length	120	Millimeter